CurrentAetnaPolicy N/A

Medication Precertification Request

Aetna precertification request form for Lamzede (velmanase alfa-tycv) used to collect patient, prescriber, dispensing, diagnosis, and clinical information required to request authorization for initiation or continuation of therapy, including setting-specific questions and documentation requirements.

Policy Summary

PayerAetna

PolicyMedication Precertification Request

Policy CodePolicy N/A

Change TypeInformational

Effective Date

Next Review Date

Key ActionSubmit completed Lamzede Medication Precertification Request form with all required clinical documentation to Aetna Precertification Notification (Phone: 1-866-752-7021, Fax: 1-888-267-3277).

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Product covered via precertification form

3Key diagnostic/response documentation items

Policy summary and purpose

Aetna precertification request form for Lamzede (velmanase alfa-tycv) used to collect patient, prescriber, dispensing/administration, diagnosis, product, and clinical information required to request authorization for initiation or continuation of therapy. The form captures patient demographics and contact details, insurance and Medicare/Medicaid information, prescriber credentials and contact, dispensing provider and place of administration, product dose and frequency, primary and other ICD diagnosis codes, and required clinical documentation and setting‑specific questions (e.g., infusion setting, prior adverse events, anti‑drug antibodies, venous access issues, behavioral/functional limitations, medical instability) to support appropriate setting and continuation decisions.

Required clinical information for precertification

All required clinical information must be completed for all precertification requests:

ALL of the following

ALL of the following
- Indicate whether request is start of treatment (start date) or continuation of therapy (date of last treatment).
- Provide patient demographic and contact information (name, DOB, weight, height, allergies).
- Provide insurance information (Aetna Member ID, group, other coverage details, Medicare/Medicaid status and IDs if applicable).
- Provide prescriber information (name, credentials, address, phone, NPI, license, specialty).
- Provide dispensing provider/administration information (place of administration, administration CPT codes if applicable, dispensing provider/pharmacy selection and contact details).
- Provide product information (Lamzede dose and frequency).
- Provide diagnosis information: primary ICD code and any secondary/other ICD codes.
- Infusion‑setting specific questions
  - Indicate whether infusion is in an outpatient hospital setting (Yes/No).
  - Has patient experienced an adverse event with the requested product that has not responded to conventional interventions or had a severe adverse event during/immediately after an infusion? (Yes/No)
  - Has patient developed laboratory confirmed anti-velmanase alfa-tycv antibodies which increases risk for infusion-related reactions? (Yes/No)
  - Does patient have severe venous access issues requiring special interventions only available in outpatient hospital setting? (Yes/No)
  - Does the patient have significant behavioral issues and/or physical or cognitive impairment that would impact safety of infusion therapy AND patient does not have access to a caregiver? (Yes/No). If yes, provide description.
- Diagnosis verification for alpha-mannosidosis
  - Does the patient have a diagnosis of alpha-mannosidosis? (Yes/No)
  - Initiation-specific confirmation
    Will the drug be used for treatment of non-central nervous system manifestations of alpha-mannosidosis? (Yes/No)
    Was the diagnosis confirmed by documented deficiency of alpha-mannosidase activity measured in blood leukocytes or fibroblasts? (Yes/No)
    Was the diagnosis confirmed by genetic testing documenting a mutation in the MAN2B1 gene? (Yes/No)
  - Continuation-specific response documentation: For continuation requests, documentation that the patient has demonstrated a response to therapy (examples: improvement in 3-minute stair climbing test [3MSCT] from baseline, improvement in 6-minute walking test [6MWT] from baseline, improvement in forced vital capacity [FVC, % predicted] from baseline, reduction in serum or urine oligosaccharide concentration from baseline).

What the provider must do

Prior Authorization

Precertification submission required

Submit the completed Lamzede Medication Precertification Request form with all required clinical documentation to Aetna Precertification Notification. For Medicare Advantage Part B members, use the Medicare request form.

Phone: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277

Documentation Required

Diagnosis confirmation documentation

For initiation requests, provide diagnostic confirmation of alpha-mannosidosis by documented deficiency of alpha-mannosidase activity measured in blood leukocytes or fibroblasts and/or by genetic testing documenting a MAN2B1 mutation, and indicate that the drug will be used to treat non–central nervous system manifestations. For continuation requests, provide objective evidence of clinical response such as improvement in 3-minute stair climbing test (3MSCT), 6-minute walking test (6MWT), forced vital capacity (FVC, % predicted) from baseline, or reduction in serum or urine oligosaccharide concentration from baseline.

Documentation Required

Infusion setting and risk documentation

Document the place of infusion/administration and provide history relevant to infusion risk that may justify outpatient hospital administration, including prior infusion reactions, laboratory‑confirmed anti‑velmanase alfa-tycv (anti‑drug) antibodies, severe venous access issues requiring special interventions, significant behavioral/functional limitations or lack of caregiver support, or medical instability (cardiovascular, respiratory, renal, or other) that cannot be managed in alternate settings.

Billing Rule

Provide administration CPT codes if applicable

If the product will be administered in a clinical setting, indicate the administration CPT code(s) on the precertification form; these codes will be used for billing.

Provide administration CPT code(s) on the form
Codes provided will be used for billing

Clinical background and definitions

Purpose: to gather the information Aetna needs to evaluate precertification requests for Lamzede (velmanase alfa-tycv), an enzyme replacement therapy for alpha-mannosidosis. The form collects clinical and diagnostic confirmation (enzyme activity and/or MAN2B1 genetic testing for initiation; objective measures of clinical response for continuation), product dosing/frequency, and infusion‑setting details and risk documentation to determine appropriate administration setting and whether continuation of therapy is supported.

Definitions

TermAlpha-mannosidosis

DefinitionA rare lysosomal storage disorder caused by deficiency of alpha-mannosidase, diagnosable by enzyme activity testing and/or MAN2B1 genetic testing.

OpenPayer

Medication Precertification Request

Policy summary and purpose

Required clinical information for precertification

What the provider must do

Requested coding fields on form

Clinical background and definitions

Document changes